A Study of ARRY-334543 in Patients With Advanced Cancer

This is a Phase 1 study during which patients with advanced solid tumors will receive a new formulation of investigational study drug ARRY-334543. Patients will receive increasing doses of study drug in order to achieve the highest dose possible that will not cause unacceptable side effects. The patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. In addition, the effect of food on the new formulation will be evaluated. Approximately 24 patients from Canada will be enrolled in this study (Active, not recruiting).

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Center at Hamilton Heath Sciences
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Histological or cytological evidence of malignancy.
• Patients with advanced solid tumors who are no longer candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
• Cardiac ejection fraction ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition (MUGA).
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
• Additional criteria exist.

Key Exclusion Criteria:

• Uncontrolled brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days).
• Use of an investigational medication or device within 30 days prior to first dose of study drug.
• Major surgery within 30 days prior to first dose of study drug.
• Radiotherapy or chemotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
• Active, uncontrolled infection requiring systemic antibiotic therapy or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment.
• Pregnancy or lactation.
• Known positive serology for the human immunodeficiency virus (HIV), 'active' hepatitis B and/or hepatitis C.
• Additional criteria exist.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARRY-334543	Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral; single dose and multiple dose, escalating

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Characterize the safety profile of the new formulation of study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.	Duration of study
Establish the maximum tolerated dose (MTD) of the new formulation of study drug.	Duration of study
Characterize the pharmacokinetics (PK) of the new formulation of study drug (in terms of plasma concentrations) when administered in a fed versus fasted state.	Day 1 and Day 8
Assess the exposure of the new formulation of study drug in terms of plasma concentrations.	Duration of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Assess the efficacy of the new formulation of study drug in terms of tumor dimension assessment.	Duration of study

Collaborators and Investigators

• Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer
• Investigators: Study Director: Pizer CT.gov Call Center, Pfizer

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: March 12, 2008
• First Submitted That Met QC Criteria: March 12, 2008
• First Posted (Estimate): March 18, 2008

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 4, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ARRAY-543-103